Food Law


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Packaging, Labeling, Transporting, Storing

Food processing is a multi-step process. This page reviews laws that address several of these steps: packaging, labeling, transporting, and storing.


Topics addressed on this page:

  • Packaging (to avoid misbranding and adulteration of the food product)
  • Labeling (to assure the consumer is informed and the food product is not misbranded)
    • Most foods are overseen by FDA
    • Meat and poultry products are overseen by USDA FSIS
    • Other consumer products (e.g., alcohol beverages, etc) are overseen by other federal agencies
  • Sanitary transportation (to avoid adulteration of food products)
  • Storage of ingredients (to avoid adulteration)
  • Storage of product (to avoid adulteration)



  • Federal statutory law states that a food product is misbranded(and thus prohibited from being sold) if the container is misleading. 
    • "A food shall be deemed to be misbranded ... (d) ... If its container is so made, formed, or filled as to be misleading." 21 U.S.C. §343(d)
  • A past practice has been to not completely fill the package.  Excessive "slack fill" and deceptive containers are prohibited by U.S. federal law.  The FDA regulation prohibiting misleading containers is codified at 21 CFR 100.100
    • "a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading. (a) A container that does not allow the consumer to fully view its contents shall be considered ... misleading if it contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein."
  • Also see FDA regulations addressing Fill Standards:
    • 21 CFR 130.12  addresses methodology for measuring and calculating "the fill" of a container
    • 21 CFR 130.14(b) regulates the labeling of food product of "substandard quality" and "substandard fill."


A second consideration with respect to packaging is whether the container may cause the food to be adulterated.

  • Packaging materials are considered an "indirect food additive;" see 21 CFR parts 174-178.  Restated, improper packaging materials could cause the food product to be considered adulterated.
    • Indirect food additives are defined as materials that come into contact with food as part of packaging, holding, or processing; indirect food additives are not intended to be added directly to, become a component, or have a technical effect in or on the food.  The following regulations provide details as to what substances can be used as indirect food additives (e.g., packaging).  A substance that is not specified in these regulations may not be used for packaging food.
      • 21 CFR 175 Adhesives and Components of Coatings
      • 21 CFR 176 Paper and Paperboard Components
      • 21 CFR 177 Polymers
      • 21 CFR 178 Adjuvants, Production aids, and Sanitizers (The substances addressed in this regulation extend beyond packaging materials; you will want to review 9 CFR 178 in the future again when considering production equipment and sanitizing equipment and the facility)
  • The basic premise is that "nothing may contact food (including packaging) unless there is a regulation allowing the item to contact food."  Therefore, the focus at this time is on "what packaging materials are allowed by regulation to contact food."
    • Indirect food additives (e.g., packaging) may be only used under conditions of good manufacturing practice; that is, the quantity 1) does not exceed the amount reasonably required to accomplish the intended effect in the food, 2) shall not exceed any prescribed limitations, 3) shall not be intended to accomplish any physical or technical effect in the food except as permitted by regulation, and 4) the article that contacts food shall be of a purity suitable for its intended use.
  • As discussed in another section, firms can file a petition requesting that FDA issue a regulation allowing the use of an indirect food additive; see 9 CFR Part 171 (the statutory basis for this regulation is 21 U.S.C. 348).
  • The regulations for packaging materials for foods subject to USDA FSIS oversight (that is, meat and poultry) are the FDA regulations; USDA authorizes this reliance on FDA regulations in 9 CFR part 317.24.


Is there any expectation that the packaging employ a method to prevent tampering with the food product?

  • For several decades, drug manufacturers have been required to use "tamper-proof" packaging.  Is there a comparable expectation for food manufacturers?
  • Will tamper-proof food packaging be incorporated into "food defense" to protect the food product from an intentional attack?  Currently, food defense (discussed in another section) focuses on management, staff, visitors, facility and operations (e.g., see Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance at  There is no mention of food packaging.  Might that change in the future?

In summary, food that is not packaged according to FDA regulations will be considered adulterated and prohibited from being sold.


The next topic is labeling.  If the food package is not properly labeled, the food will be considered misbranded.


Food Labeling

Food Drug and Cosmetic Act (administered by FDA) prohibits the sale of misbranded food which implies that food products must be properly labeled.

As stated previously, consumers will make the final decision about what they consume.  The attitude in the United States (and apparently many other nations) is that government will not regulate consumer decisions.  However, there is an expectation that consumers will make "better" decisions if they have information with which to make decisions.  Accordingly, society (through government) mandates that food firms provide accurate information about their product to consumers so consumers can then make their decisions.  Much of this information is expected to be available at the time and place the consumer decides to purchase the food item.  Labels have been identified as the vehicle by which the consumer information is to be provided.  This section introduces U.S. laws and regulations directing the labeling of food products.


Major U.S. Acts Addressing Food Labeling

  • Fair Packaging and Labeling Act (administered by FDA)

"Informed consumers are essential to the fair and efficient functioning of a free market economy. Packages [of consumer commodities] and their labels should enable consumers to obtain accurate information as to the quantity of the contents and should facilitate value comparisons." 15 U.S.C. §1451

"consumer commodity ... does not include ...any meat or meat product, poultry or poultry product, or tobacco or tobacco product" 15 U.S.C. §1459

Meat and poultry labeling is regulated by the USDA; as discussed subsequently.

  • Nutritional Labeling and Education Act

"...the Nutrition Labeling and Education Act of 1990 (NLEA), which, among other things, requires nutrition labeling for most foods (except meat and poultry) and authorizes the use of nutrient content claims and appropriate FDA-approved health claims. Meat and poultry products regulated by USDA are not covered by NLEA. However, USDA's regulations closely parallel FDA's rules..." taken from The Food Label (this links no longer works).

  • Food Allergen Labeling and Consumer Protection Act of 2004 (this link no longer works)

All packaged foods regulated by FDA must comply with food allergen labeling requirements after 2005.  A "major food allergen" is an ingredient that is one of five foods or one of three food groups (or is an ingredient that contains protein derived from one of the eight categories): milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts or soybeans.  These foods or food groups account for 90 percent of all food allergies. Although there are other foods to which sensitive individuals may react, the labels of packaged foods containing these other allergens are not required to specify those ingredients or substances as allergens.


Food Labeling Statutes and Regulations

Food labeling requirements are based on statutory laws enacted by Congress and subsequent regulations issued by the implementing federal agency.  These statutes and regulations are found in their respective codes; this is not a complete list of all U.S. federal food labeling  laws.


Industry Guidance on Food Labeling

To assist food businesses comply with food laws (including food labeling laws), the responsible agencies are increasingly publishing guides and fact sheets written for a business audience (rather than the legalese of statutes and regulations).  These explanatory publications offer a good introduction to the statutes and regulations.


Improperly labeled food is Misbranded food

  • Note -- the discussions of ingredients, sanitation, manufacturing processes, etc (including contact substances from packaging) are addressed under the broad prohibition against adulterated food. We now turn our attention to misbranding.
  • Labeling regulations significantly blur the distinction between food safety issues and nutritional issues.  Many labeling requirements address the goal of providing consumers information on which they can base their food purchasing decisions, but the emphasis is on nutritional information. There are few labeling regulations that directly address food safety concerns, e.g., disclosure on labels of allergens used in manufacturing the food. However, it is appropriate to study labeling requirements because the food must be properly labeled for it to be sold in interstate commerce, and the same agencies (FDA and FSIS) have primary responsibility for both food safety and food labeling.
  • The jurisdictional distinction between FDA and USDA FSIS continues in regulating labels; as a general rule, FDA regulates the labeling of all food except those regulated by USDA FSIS (i.e., meat and poultry products) and those regulated by Alcohol and Tobacco Tax and Trade Bureau (TTB).
    • "...commercially processed egg products, and meat and poultry product, including combination products (e.g., stew, pizza), containing two percent or more poultry or poultry products, or three percent or more red meat or red meat products ... are regulated by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS)."
  • Responsibility for promulgating and enforcing regulations with respect to labeling distilled spirits, wines, and malt beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of Treasury.
    • BUT -- beers which are not made from both malted barley and hops (but are instead made from substitutes for malted barley such as sorghum, rice or wheat, or are made without hops) do not meet the definition of a malt beverage.  Such products are not subject to the labeling, advertising, and other provisions of the TTB regulations.  An alcoholic beverage not covered by the TTB labeling regulations is subject to ingredient and other labeling requirements of FDA regulations.
    • Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance at


Requirements for Labeling Food Products

    Five basic label requirements for food: product name, quantity of content, nutritional information, ingredients, and manufacturer or distributor. These five requirements are addressed in subsequent subsections.


    The following list identifies several FDA guidance documents that address food labeling.  Be certain to skim these pages and then focus on specify topics or discussions relating to the food you are interested in.


    Parts of a Food Label

    • You may want to gather three or four food packages as you read this section; take a few moments to identify each of the following components on each package.
    • Principal display panel(PDP)
      • The PDP is the "portion of the package label that is most likely to be seen by the consumer at the time of purchase."  The front of the package??
      • The PDP must indicate the Name of product 
      • The PDP must also indicate the Net quantity of contents in U.S. and metric terms in legible type and size; this information must be printed in a line parallel to base of package.
      • No qualifying terms, such as "big" or "large", may be included in the "quantity of contents" statement.
      • These requirements pertaining to the PDP primarily stem from The Fair Packaging and Labeling Act, 1966 15 U.S.C. §§1451-1461; regulations are found at 21 CFR part 101 subpart A


    • Information panel
      • The information panel is the "panel [on the package] immediately to the right of the PDP"
      • The information panel is the location to place the nutrition information.
      • The information panel "refers to the label statements that are generally required to be placed together, without any intervening material"; that is, the nutrition information must be placed exactly as required by federal law (federal regulations).
      • An FDA guidance document:  Nutrition Labeling:  General, Nutrient Declaration, etc
      • Additional information from FDA guidance document:  Nutrition Labeling (cont'd) : Label Formats/Graphics Requirements (general label, bilingual format, variety packs, simplified format, trans fat labeling, serving size, exemptions, etc)
      • Regulations for nutrition labeling are found at 21 CFR 101.9
      • Topics relating to the nutrition labeling are "serving size" and "number of servings in the package"
        • Serving size is not set by government; it is determined by processor; a serving size will likely be acceptable as long as it is logical; see 21 CFR 101.12
        • Per serving information presented in terms of content and % daily value
        • Calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugar, protein, vitamins, A, C, calcium and iron
        • Other nutrition information is included voluntarily
      • Formats are standardized and specific labels.
      • Nutrition label is required on most, but not on all, products; examples of exceptions:
        • individual items such as candy bars from a box -- nutrition information is on box, individual items labeled as "not for sale as individual items;" selling individual items labeled in this manner violates the labeling law
        • wholesale containers -- nutrition information must be provided by the seller to the purchaser by another means such as a flyer
        • container is too small to include all nutritional information (such as individual sugar packet) -- include as much information as possible
      • Statement of ingredients
        • The information panel must list ingredients in descending order of predominance by weigh; see 21 CFR 101.4
          • The information panel must identify Food Allergens
            • Labeling Allergens
            • "Effective January 1, 2006, the Food and Drug Administration (FDA) is requiring food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods." excerpt from FDA.

        Recommended Reading: FDA's guidance for industry at "Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers"

        Statutes: 21 U.S.C. §321(qq) (definition of major food allergen) and 21 U.S.C. §343(w) (food containing major food allergen will be considered misbranded unless properly labeled; this statute also provides businesses the opportunity to petition for an exemption from the labeling requirement).

        Apparently no regulations yet (fall 2014).

      • The information panel must provide the name and address of manufacturer, packer, or distributor; see 21 CFR 101.5.
      • Statements/information on the information panel cannot be interspersed with or separated by other information; the other information has to follow these three items.
    • Advertisement Panel
      • The remainder of the package may include instructions/directions for product preparation, UPC label, warnings (such as "hot when prepared"), quality guarantee statements, etc as long as the overall label is not misleading.  Misleading information on the package outside the PDP and information panel may still render the product as misbranded and illegal to sell.


    • Labeling Product Claims
    • To promote their product, some food businesses may want to include claims about the characteristics of their product.  Claims made about food products are regulated.  For those claims that are regulated, the claim must abide by the FDA regulation.  If the food business is making a claim that is not regulated, the claim can be made as long as the claim is not misleading.  The following points pertain to product claims that are regulated.
      • Claims need to be appropriately labeled to prevent the food from being declared "misbranded".
      • FDA regulations define Nutrition Content Claims and Health Claims.
      • Relevant Regulations:  Nutrition Claims at 9 CFR 101.13 and 101.54 to 101.69; Health Claims at 9 CFR 101.14 and 101.70 to 101.83; Other claims at 101.91 to 101.95.
      • Chapter 8 of the FDA Food Labeling Guide discusses claims in a Q&A format.  This discussion addresses
        • Nutrition Claims:  "a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "low fat," "high in oat bran," or "contains 100 calories")."
        • Health Claims:  "any claim made on the label of a food that expressly or by implication characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include any communication that suggest a relationship between the presence or level of a substance in the food and a disease or health-related condition.  Health claims are limited to claims about disease risk reduction (and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease). Health claims are required to be reviewed and evaluated by FDA prior to use."
        • Qualified Health Claims:  "Qualified Health Claims differ from Health Claims in that Qualified Health Claims must be accompanied by a disclaimer or otherwise qualified.  Qualified Health Claims provide health claims based on less scientific evidence than is required for a Health Claim, as long as the Qualified Health Claims does not mislead the consumers."
        • Function and Structure Claims:  "Dietary supplement labels may bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans.
      • Appendices A, B, C & D to the Labeling Guide provide additional details about Nutrition Claims, Health Claims and Qualified Health Claims.
        • Nutrition Claims, for example, define "free," "low," and "reduced/less."


    Dates on the Label

    • What does the date on the product mean?

      "What does the date on the package mean? "Open Dating" (use of a calendar date as opposed to a code) on a food product is a date stamped on the package of a product to help the store management determine how long to display the product for sale. It is a quality date, not a safety date. "Open Dating" is found primarily on perishable foods such as meat, poultry, eggs, and dairy products. If a calendar date is used, it must express both the month and day of the month (and the year, in the case of shelf-stable and frozen products). If a calendar date is shown, immediately adjacent to the date must be a phrase explaining the meaning of that date such as "sell by" or "use before." A "sell-by" date tells the store how long to display the product for sale. You should buy the product before the date expires. A "use-by" date is the last date recommended for the use of the product while at peak quality. In both cases, the date has been determined by the food processor. "There is no uniform or universally accepted system used for "Open Dating" of food in the United States. Although dating of some foods is required by more than 20 states, there are areas of the country where much of the food supply has almost no dating." Excerpt from FSIS' The Poultry Label Says "Fresh"

      Also see Product Dating at FSIS Labeling Policies, FSIS Food Product Dating, and FSIS Regulation for Package Dating.

    Few foods are required to be "dated" in the United States.

    • Since 1972, FSIS has required poultry products to include a date of packing, either as a calendar date or a code. FSIS has permitted the use of a sell-by or use-by date in lieu of the required date of packing.
      There is no regulation requiring meat products to have a calendar date. However, if a federally inspected establishment has voluntarily placed a calendar date on meat products, such a date cannot be removed or changed by a retailer while the product remains in its original packaging. If a calendar date is used on labeling for either meat or poultry, a phrase explaining the meaning of such date, in terms of "packing" date, "sell by" date, or "use before" date, must be right next to it.
    • "With the exception of infant formula, the laws that the Food and Drug Administration (FDA) administers do not preclude the sale of food that is past the expiration date indicated on the label. FDA does not require food firms to place "expired by", "use by" or "best before" dates on food products. This information is entirely at the discretion of the manufacturer."


    Labeling meat, poultry, and egg products

    • Labels for meat and poultry products must be pre-approved by USDA.9 CFR 317.4
    • Labeling meat products (administered by USDA FSIS)
      • 9 CFR 317 including nutritional labeling (9 CFR 317.300 - 317.400)
    • Labeling poultry products (administered by USDA FSIS)
      • 9 CFR 381, more specifically, sections 381.115 to 381.144 and 381.400 to 381.500; product name, ingredients, quantity of contents, weight, handling instructions, additives, manufacturer identification, date of packaging, and nutritional labeling.
    • Suggested Label Submission Checklist (USDA FSIS web page) "A checklist which provides guidance on the preparation and submission of label applications."


    Country of Origin Labeling

    "Country of Origin Labeling [COOL] is a labeling law that requires retailers, such as full-line grocery stores, supermarkets, and club warehouse stores, notify their customers with information regarding the source of certain foods. Food products, (covered commodities) contained in the law include muscle cut and ground meats: beef, veal, pork, lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng... [USDA] AMS is responsible for administration and enforcement of COOL."  See  Also see 7 CFR parts 60 and 65.

    COOL has been a political issue as Congress debated and enacted the statute; the political positioning continued for a decade as USDA tried to promulgate regulations to implement the law.  Some interested parties argued that consumers want to know where the products are being produced; others argued that the cost of tracking the product so the COOL labeling was accurate would negatively impact the food industry.

    To be beneficial, COOL labeling needs to be available to the consumer as they make their purchase decisions, thus the regulation directs retailer to provide COOL labeling (7 CFR 65.300(a)).  But in order for the retailer to accurately label the retail product, the preceding handlers, processors and others in the supply chain need to track the movement of the product and to accurately convey COOL information with the product. Accordingly, the regulations also address these responsibilities (7 CFR 65.500(b)).

    • Note that COOL is overseen by USDA Agricultural Marketing Service (AMS); this is a different agency than USDA FSIS which oversees food safety concerns within the USDA.  Also note the foods subject to COOL; some appear to be FDA foods (that is several types of nuts).  Despite FDA's long-time responsibility of regulating these foods, USDA AMS has been directed Congress to oversee the COOL labeling of these foods.


    Irradiated meat and poultry -- 9 CFR §424.22(c)

      • "(1) General requirements. Meat food and poultry products may be treated to reduce foodborne pathogens and to extend product shelf-life by the use of sources of ionizing radiation as identified in 21 CFR 179.26(a). Official establishments must irradiate meat food and poultry products in accordance with 21 CFR 179.26(b), the Hazard Analysis and Critical Control Point (HACCP) system requirements in [9 CFR part 417], and the provisions of this section. "
      • "(4) Labeling. (i) The labels on packages of meat food and poultry products irradiated in their entirety, in conformance with this section and with 21 CFR 179.26(a) and (b), must bear the logo shown at the end of this paragraph (c)(4)(i). Unless the word "Irradiated'' is part of the product name, labels also must bear a statement such as ``Treated with radiation'' or "Treated by irradiation.'' The logo must be placed in conjunction with the required statement, if the statement is used."
      • Also see FSIS Irradiation Resources


    Labeling egg products --  FDA and USDA share labeling authority; 9 CFR 590.411 and 9 CFR 590.680


      Have the Labeling Requirements been Met?

      • Label Approval
        • FDA does not pre-approve labels; FDA may offer suggestions if the processor inquires; FDA will enforce law after the label is put in use.
          • No pre-approval of label is required by FDA for products under its jurisdiction. It is the responsibility of the manufacturer or importer of a food to comply with current food labeling regulations." See question L56 of A Food Labeling Guide Chapter VII--Miscellaneous
        • USDA requires the label to be pre-approved (e.g., 9 CFR 412);
          • See FSIS USDA Labeling & Label Approval, for example.
          • Pre-approval of label by USDA is required for products under its jurisdiction; e.g., 9 CFR 412
          • "No final labeling shall be used on any product unless the sketch labeling of such final labeling has been submitted for approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and approved by such division ..."
        • Accordingly, the steps a food processor will take in developing and beginning to use a label depends on whether the product is regulated by FDA or USDA.


      Labeling for Special Circumstances

      • Food service products ; e.g., 21 CFR 101.10
        • "Nutrition labeling ... shall be provided upon request for any restaurant food or meal for which a nutrient content claim ... or a health claim ... is made, except that information on the nutrient amounts that are the basis for the claim (e.g., ``low fat, this meal provides less than 10 grams of fat'') may serve as the functional equivalent of complete nutrition information..."
      • Wholesale - multi-units; e.g., 21 CFR 101.100( a)(2) and (d)
        • Food is exempt from having a "declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients [if the] ... food [is] received in bulk containers at a retail establishment [and] ... displayed to the purchaser with either: (i) The labeling of the bulk container plainly in view, provided ingredient information appears prominently and conspicuously ... or (ii) A counter card, sign, or other appropriate device bearing prominently and conspicuously ... the information required to be stated on the label ... "
        • "... a shipment or other delivery of a food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of ... movement in interstate commerce ... from compliance with the labeling requirements ... if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or (2) In case such person is not such operator, such shipment ... is made ... under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, ... will ensure [( if such specifications are followed)] that such food will not be adulterated or misbranded ... Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment ... of such food from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them."
      • Nutritional labeling of raw fruits, vegetables, and fish -- this is voluntary; see 21 CFR 101.42 to 101.45
        • "The Food and Drug Administration (FDA) urges food retailers to provide nutrition information ... for raw fruit, vegetables, and fish at the point-of-purchase. If retailers choose to provide such information, they should do so in a manner that conforms to the guidelines..."


      Labeling products regulated by Alcohol and Tobacco Tax and Trade Bureau


      Product Coding

      Not the same as labeling even though it is part of the packaging; coding is intended to help identify the source of the food item.

      Food firms are allowed to develop their own coding system. The firms decide the level of detail. For example, do they want to be able to identify the time of day of processing, or just the shift during which the food was processed? More detail allows the firm to "pin point" when a product was processed, but each level of detail perhaps adds cost to the business operation.


      Labeling requirements of other nations

      • Other nations also have labeling requirements; e.g., REGULATION (EU) No 1169/2011 on the provision of food information to consumers 25 October 2011at
      • (begin on page 25 of the pdf).   These requirements must be met by food businesses that want to export to these other nations. For example:
        • List of mandatory particulars (a) the name of the food; (b) the list of ingredients; (c) any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II causing allergies or intolerances used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; (d) the quantity of certain ingredients or categories of ingredients; (e) the net quantity of the food; (f) the date of minimum durability or the ‘use by’ date; (g) any special storage conditions and/or conditions of use; (h) the name or business name and address of the food business operator referred to in Article 8(1); (i) the country of origin or place of provenance where provided for in Article 26; (j) instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions; (k) with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume; (l) a nutrition declaration.
      • Codex labeling standards:
      • Recall that a businesses wanting to import to the United States must comply with U.S. food laws, including U.S. food labeling laws.


      Food Transportation

      Food safety from "farm to fork" includes transportation. Recall that the statutory definition (9 U.S.C. 342(a)(4))  states that food would be considered adulterated "if it [the food product] has been prepared, packed, or held under insanitary conditions whereby it MAY [emphasis added] have become contaminated with filth, or whereby it MAY [emphasis added] have been rendered injurious to health."  Clearly, food transported in a dirty vehicle has been "held" under conditions that "could" contaminate the food product.

      Several incidents in the past decades have spotlighted the importance of adopting practices to reduce the risk of adulteration as a result of transporting food.  One incident was shipping milk in a truck bulk tank after the vehicle had been used to move liquid eggs.  This milk was then processed into ice cream that caused consumer illnesses.  This and other incidents caught national attention.

      Congress responded by authorizing the Dept. of Transportation to address the issue; see "Sanitary Food Transportation Act of 1990" -- Chapter 57 of U.S.C. Title 49. This statute directed the Department of Transportation (DOT) to develop appropriate regulations.

      DOT proposed regulations in 1993 but never finalized them. DOT proposed regulations again in 2004; never finalized these either (see  A frustrated Congress shifted the responsibility for food safety transportation to FDA in 2005.

        • 21 U.S.C. 350e FDA is authorized to "require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices ... to ensure that food is not transported under conditions that may render the food adulterated"
        • The regulations shall prescribe practices relating to (A) sanitation; (B) packaging, isolation, and other protective measures; (C) limitations on the use of vehicles; (D) information to be disclosed to a carrier and a manufacturer, (E) recordkeeping. The regulations shall list nonfood products that may, if shipped in a bulk vehicle, adulterate food that is subsequently transported in the same vehicle and nonfood products that may, if shipped in a motor vehicle or rail vehicle, adulterate food that is simultaneously or subsequently transported in the same vehicle.
        • The Secretary may waive any requirement under this section, with respect to any class of persons, vehicles, food, or nonfood products, if the Secretary determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health, and the waiver is not contrary to the public interest.
        • The DOT, USDA, EPA and other Federal agencies shall assist in carrying out this program when requested by FDA.

      Congress again grew frustrated (this time frustrated with FDA) so Congress in the Food Safety Modernization Act of 2010 directed the FDA to promulgate regulations for food transportation.

      FDA provided Guidance on the transport of juices in April 2003.

        • Guidance on Bulk Transport of Juice Concentrates

          "The purpose of this guidance is to provide industry with recommendations for appropriate control measures to use in the bulk transport of:

        • high degree Brix juice concentrate that is transported to a separate facility for final packaging or for dilution to a consumer strength concentrate and final packaging, and
        • shelf stable single strength juice that is transported in aseptic packaging to a separate facility for final packaging."

      FDA updated its Guidance on the transport of bulk milk in October 2007.

      "This guidance is designed as an aid to operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities. It identifies the kinds of preventive measures operators of these establishments may take to minimize the risk that fluid milk under their control will be subject to tampering or other malicious, criminal, or terrorist actions."


      As a food processor, what do you expect of your food transporter?  How might a food processor communicate those expectations to the transporter?  HINT -- in the contract by which the food processor hires the food transporter?  How will the food processor monitor whether the transporter is meeting the food processor's expectations?  HINT -- the food processor inspects the truck?  HINT -- the food processor requires the transporter to maintain and make available records relevant to the transport of the food product.


      Food Storage

      As stated in federal statutory law, food stored in unsanitary conditions will be considered adulterated even if the food is not contaminated.  Food warehouses and other storage facilities must be maintained so that food stored within the facility cannot be contaminated.  This expectation pertains to commodity storage at a processing plant, product storage at a processing plant, or food storage at any location even if no processing occurs.  Accordingly, all facilities in the food distribution network or system must be maintained in a manner that will not allow the food to be contaminated.

      See 21 U.S.C. 342(a)(4)

      "A food shall be deemed to be adulterated— (a)... (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health..."
      Topics or details to consider:
      • Design the storage facility to minimize risk of contamination
      • Construct the storage facility of materials that can be readily cleaned and maintained
      • Maintain the storage facility to prevent external contamination
      • Separate storage area from worker "break areas"
      • Separate storage of raw product from processed product
      • Maintain proper storage environment, e.g., temperature, humidity

      Food storage facilities are subject to inspection by federal, state and local authorities.

      Do not forget that industry standards (as expressed in a buyer's contract with a supplier) often match, exceed or precede regulatory standards.



      Food packaging is regulated to assure the package does not mislead the consumer (misbranded?) or adulterate the food.

      Food labeling is regulated to assure 1) the information does not mislead the consumer and 2) the consumer has information to make an informed decision at the time of the purchase decision.  Advertising also is regulated to assure the consumer is not being provided misleading information.

      The storage and transportation of food and food ingredients are regulated to reduce the risk that the product becomes adulterated at any step through the food system.


      This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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